Taking stock of the MDSAP

Taking stock of the MDSAP

The Medical Device Single Audit Program (MDSAP) of the International Medical Device Regulators Forum (IMDRF) moved into its pilot phase on January 1, 2014. After over a year, the initiators and participants – five national regulatory authorities in addition to auditing organizations and manufacturers – have now met for an exchange of experience.

The regulatory authorities’ goal is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization to satisfy the needs of multiple regulatory jurisdictions.

After the first pilot audits, feedback on the MDSAP was very positive, and Japan has announced its intention to participate in the MDSAP future.

Lessons learned

Representatives of the regulatory authorities in Australia (TGA), Brazil (ANVISA), Canada (HC), the USA (FDA), and Japan (MHLW/PMDA) – the latter previously in the capacity of an observer – met for an exchange of experience over the MDSAP in June 2015. Feedback from the first MDSAP audits were shared by the auditing organizations and the manufacturers that had joined the program as voluntary participants. The regulators were open to the feedback concerning the requirements and procedures for the audits. One point of discussion was the short time frame of only 15 days for manufacturers to respond to nonconformities. Another discussion topic was how to improve the approach to audit planning.

Manufacturers welcome MDSAP

The participating manufacturers were all satisfied with their participation and were unanimous in their support of the MDSAP – not least in view of the advantages that a single audit could mean for them. They also delivered positive reports of their experiences with the first audits and agreed that costs were not an obstacle, as the MDSAP audits can be integrated into other schemes such as the European Medical Device Directive (MDD). All participants confirmed that the MDSAP is valuable and should proceed to thestage of full implementation.

Japan: From observer to participant

The meeting also included advanced training for the auditing organizations, in which the regulators clearly set their expectationsfor application of the program. In addition, the Japanese regulatory authority announced its intention to participate in the MDSAP in future instead of being an observer. The Japanese Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticaland Medical Devices Agency (PMDA) will announce further details at a later stage.